1. Pink Sheet
  2. >>Rare Diseases

India Exempts Rare Disease Drugs, Keytruda From Customs Duty - Is It Enough?

India, China Likely Have Largest Numbers Of Rare Disease Patients

 
• By Vibha Ravi

India has exempted imports of top-selling oncology drug Merck’s Keytruda from customs duty as also rare disease drugs listed in the National Policy For Rare Diseases. However, patient advocacy groups feel more fiscal measures and manufacturing incentives are needed to improve access  

Red Chess Piece Among White Ones
Tackling Rare Diseases Needs More Policy Measures, Fiscal Incentives • Source: Shutterstock

A recent move by the Indian government to exempt customs duty on drugs and food items prescribed for special medical purposes and imported for personal use to treat rare diseases listed in the National Policy For Rare Diseases, 2021 is a win for groups that have been working to sensitize policy makers and regulators to the needs of rare disease patients.

Along with these drugs, Keytruda (pembrolizumab) from MSD, as Merck & Co., Inc. is known outside US and Canada - prescribed for a wide range of cancer types - has also been exempted

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Rare Diseases

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

More from Pink Sheet

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.